Impact of Monitoring Quality Indicators in Maternity Departments on Mother and Infant Health

NCT01459978 | Completed

• 1 other identifier: PHRQ1032
• Study Type: observational
• Target: 60,000
• Locations: 1 country
• Sites: 2

Brief Summary

Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM: Cumulative Sum) will increase the awareness of health care staff in maternity and permit rapid detection of a small dip in performance in order to enable prompt investigations and corrective measures when necessary , which decrease maternal and neonatal mortality and morbidity. Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity dashboard to decreases maternal and neonatal mortality and morbidity. Design: Step-wedge cluster-randomized trial with prospective analyses of collected data. Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants could be collected over 2 year's period. Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators previously selected by Delphi method. Main Outcome Measures: Composite outcome that considers multiple clinical events : mortality, adverse outcomes for women and newborn.

Conditions

Obstetric; Injury; Injury

Keywords

CUmulative SUM (CUSUM); quality indicators; obstetrics

Outcome Measures

Primary Outcomes (2)

• Indicator of mother health

  is a composite outcome taking into account : 1. \- mortality, 2. \- complications of pre-eclampsia * Hemolysis ,Elevated Liver enzymes, Low Platelet syndrome (HELLP): * Disseminated intravascular coagulation (DIC) * eclampsia * retro-placental hematoma, 3. \- postpartum hemorrhage 4. \- severe bleeding 5. \- thromboembolism: * Phlebitis * Pulmonary embolism 6. \- postpartum infections 7. \- severe perineal injury 8. \- need of intensive care transfer for women

  After 24 months

• Indicator of newborn health

  is a composite outcome of mortality and morbidity. Morbidities taken into account several clinical events: 1. \- postnatal deaths (8days 1 month) 2. \- prematurity: medical or spontaneous 3. \- low birth weight (weight less than 2 kg at 37 weeks) 4. \- maternal-fetal infection: occurring in the first hours of life (germs: B streptococcus, E. coli, streptococcus, non-B) 5. \- transfer resuscitation term 6. \- chromosomal abnormalities with absence of screening 7. \- malformations without screening and diagnostic

  After 24 months

Secondary Outcomes (1)

• Women satisfaction

  After 12 and 24 months

Study Arms (2)

Early CUSUM result group

Phase 1: 3 months testing and observation period. During this phase, rates of each quality indicator selected will be collected to adjust the acceptable and unacceptable rate set by practitioners of each maternity. Phase 2: results of the CUmulative SUM (CUSUM) will be provided for a period of 12 months (Early CUSUM result group), Phase 3: maternity will continue to receive the results of the CUmulative SUM (CUSUM) for a period of 12 months,

Other: CUmulative SUM (CUSUM) Chart

CUSUM result Delayed group

Phase 1: 3 months testing and observation period. During this phase, rates of each quality indicator selected will be collected to adjust the acceptable and unacceptable rate set by practitioners of each maternity Phase 2: the results of CUmulative SUM (CUSUM) will not be shared. Phase 3: group receive CUmulative SUM (CUSUM) result (CUSUM result Delayed group) during the same period 12 months

Interventions

CUmulative SUM (CUSUM) Chart OTHER

Intervention is described as follows: Step 1: Implementation of the CUmulative SUM (CUSUM)control chart using available medical data Step 2: Submission of monthly results to the coordinator of each participating center (if CUmulative SUM (CUSUM) results period). Step 3: When an alarm is generated, the steering committee will meet with maternity staff to find the causes of these alerts and propose

Early CUSUM result group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participating Center Ten Maternity departments in France will participate to the study (Table1)

You may qualify if:

• All deliveries during the study period:
• Regardless of the mode of delivery: vaginal delivery, cesarean section, spontaneous or induced delivery
• Regardless of the pregnancy term
• Women followed or not from the first trimester of pregnancy in the concerned maternity
• New born during the study period

You may not qualify if:

• Pregnancies that ended with foetal death in UTERO or pregnancy termination for medical reasons

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Boulkedid

Paris, 75019, France

Location

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Rym BOULKEDID

  Hopital Robert Debre, Clinical Epidemiology Unit

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: October 26, 2011
• Study Start: September 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 2, 2018

Record last verified: 2018-02

Locations

FR (2)